FIGHTING PROPs FDA PETITION

At the end of July the American News Report published my column on the Physicians for Responsible Opioid Prescribing’s (PROP) petition to the Food and Drug Administration (FDA) asking for changes in the labeling of opioid analgesics.(link to my article)

In essence, PROP wants to change the labeling for opioids that now includes use for moderate and severe pain to severe pain only.(see props petition @ www.citizen.org/documents/2048.pdf) It’s instantly discernible that PROPs strategy is to reduce the numbers of pain patients who’d be eligible otherwise to use an opioid analgesic.

Another restriction PROP asks for is that the FDA set guidelines that would only allow a patient to take no more than 100 mgs for pain on any day. This, of course, ignores the fact that many patients suffer from harrowing pain from diseases and injuries that only respond to much higher doses of opioids. If the FDA adopts this provision many patients would be sentenced to a living hell.

The third radical change that PROP petitions is to limit patient’s use of opioid analgesics to 90 days. That’s right, all you folks living with intractable pain, Andrew Kolodny et. al. would radically and, apparently, without a twinge of conscious, toss you and your families into a devouring pit of malignant pain. I continue to hope that PROP and its supporters are fully aware that pain kills. If they do, there is no evidence of it in this unbalanced approach to protecting the public from diverted medicine while protecting the needs of people with pain.

PROP cites several research papers in support of their petition. Robert Twillman PH.D. FAPM is the Director of Policy and Advocacy for the American Academy of Pain Management analyzed PROPs petition in a guest column for Pain-Topics.org NEWS/RESEARCH titled Group Petitions FDA to Change Opioid Label (http://updates.pain-topics.org/2012/08/group-petitions-fda-to-change-opioid.htm). “The petitioners include 9 statements purporting to provide scientific rationale and support for the requested label changes. These statements are based on scientific work that is as sparse as the body of evidence supporting long-term opioid therapy criticized by the petitioners as being insufficient.”

Twillman bases this statement on his thoughtful analysis of the research provided to the FDA in the petition. It is a fact that the research supporting the use of opioids and the research questioning it are at this stage of scientific inquiry suggestive at best. The need for continued reliable, dependable and repeatable research will help drive good policy.

PROPs petition has gotten a boost from Rep. Mary Bono Mack of California, who along with some House colleagues has in letter to the FDA asked that PROPs petition be put on the fast track to approval. This is not an alliance that pain activists can ignore. PROPs roll out of this petition smacked of very good public relations work. This in combination with political power needs our vigorous opposition. There can be no good coming to pain patients from this alliance. PROP is content to use political power to advance their extremist agenda. Again, I say extremist because there is nothing in this petition that comes close to protecting patients with pain.

I am now convinced that PROP and others want ultimately to prohibit pain patients from using opioid analgesics. I say this because PROPs petition looks, in my opinion, like a slippery slope. First they will only allow you 100 mgs. no matter how much you use to lessen your pain. Next, they’ll limit you to 90 days, after which, you are on your own. If you are tortured by “moderate” pain, well, there’s always ibuprofen.

Twillman in the same article above cited research by “Hall et al. [2008, ref below at end] for alcohol and other drugs, and that 56% of cases had no prescription for an opioid. The solutions for these problems differ greatly, depending on the mediating found that 79% of people dying from overdoses involving opioids tested positive factors between prescription and overdose death.”

Again, this isn’t definitive. Recognizing that this research needs to be repeated with different samples, its findings support what pain patients have come to ask: why should we bear the brunt of this war on drugs when it is people illicitly using our medicines and stupidly combining them with other drugs and washing it all down with a pint of Jack? I don’t mean this heartlessly as any death due to an overdose is tragic. But the question deserves an answer.

Readers can directly oppose PROPS petition by going to an editor’s edition to Twillman’s article at www.Regulations.gov: “Physicians for Responsible Opioid Prescribing – Citizen Petition; Docket ID: FDA-2012-P-0818” [click here]. The petition document is available there as a PDF. Also, there is a “Comment Now!” button at that site [or click here], so those interested can type-in comments or submit documents with comments directly to the FDA.

19 Responses to FIGHTING PROPs FDA PETITION

Hi, I have Arachnoiditis, a rare spinal cord disease, which causes very bad intractable chronic pain that I have to face 24/7. These Doctors, must not know or understand what chronic pain is. I cannot believe what they are asking of the FDA, to limit our Opioid use. I have had many invasive procedures done, and even tried the Pain Pump..All these treatments did not help my Pain..I have been on MS Contin and roxicodone for 7 yrs, and I can say without a doubt that this medicine helps my pain..IF it did not help me, why would I continue to take it..I am not addicted to my meds, I am dependent on them to be able to live a somewhat normal life..I, myself, could not live with the pain this disease causes and if our meds our taken away from us, I believe it will only lead to a countless amount of suicides..Do these Dr’s not understand the generations of baby boomers getting older? No wonder there is an increase of use. We are getting older and the older you get the more painful issues you deal with..I was given my Disease with an Epidural into my spine, in which he punctured my dura, I did not ask for this..My life has changed so much, with a loss of friends, and relationships. Not everyone understands these invisible diseases, and with me, the only relief I get is thru my Opioids. I could not live on 100 mg a day, with a short span of 90 days. How can they even ask of this with all the disease out in this world. It is estimated that there are 100 million Americans with chronic pain, and that is not counting the rest of the world. I think PROP needs to reconsider what they are asking for. What goes around comes around..One day these Dr’s will experience pain, and chronic Pain..What will they do then?

OH God, Becky, I know you, I know of your plight, mine is the same one. We share this disease. Why, why, why, won’t they listen. Is it their job in life to ruin people who were decent, and productive members of society? I was an medic, and RN for more years than some of these Dr’s have been alive………..oh well, to tired, and I hurt,,,,,,,,doc

I agree with Mary Vargas! Where does PROP get its money and the staff to do the public relations blitz that accompanied the petitions being sent to the FDA. That was a smooth, well coordinated public relations campaign! So Dr. Andrew Kolodny and PROP, where DO you get your money?

Anybody in the Tallahassee Florida area is invited to attend the Rally in Tallahassee to restore patients rights to opioid medication. This first of a kind event will be held at the Capital Courtyard from 10:00am – noon Wednesday September 12th 2012. Physicians, Pharmacists and Chronic Pain Patients will bring awareness of the shortcomings of the Pill Mill Bill and the difficulties pain patients have in filling their prescriptions. Call Donna Ratliff the Director of FFFPCAN at: 813-634-3829 or
Email Dr. Jeff Fudin http://paindr.com/prompt-info/

Becky Roberts is right to say that she didn’t ask for the pain she deals with 24/7. Most of us dealing with chronic pain agree that opioids provide relief that can allow us a portion of our lives returned with the proper dose. We are all individuals and treatment should reflect that what may seem like high dosage for one person is just barely enough for another. To put a template out for everyone with pain to have to abide by and say that they can only have 90 days of treatment is extremely harsh. The one who put together this PROP petition must be in great physical shape and believes they will remain so against all odds or has been compensated with money in major quantity to use their good name because the table could turn on a dime. Yes would this group like to walk a mile in her shoes. A mile is quite a task for some. For some just being able to function at a percentage of what was normal before is difficult. Then take away the pain medication and I don’t think the results will be a petition that promises to take away that which gives the only relief that there is. Then consider facing that everyday of the rest of your life because someone who doesn’t even know you has decided to ban your relief possibilities. Bless you Becky and the other millions who are out there too. I am also concerned about this petition for I have just found my pain managment plan after trying all sorts of different medications with my physician and now they want to give all that pain back to me. For Shame, For Shame……..

Thank you anonymous for your caring, thoughts, All of us with chronic pain should be concerned about this Petition. The one thing they do not have is proof of long term side effects, nor do they have the proof, that these medication help so many chronic pain patients to get out of bed every morning. They must be in excellent shape as you say, but our bodies do get old and worn out and one day these people will need them, and they will have taken away their ability of a some what quality of life, when their turn comes for Pain.
I was given this pain through a Doctor’s mistake when he gave me a series of 3 ESI’s. I have suffered lose of my career, my family and friends. I am on SSDI now b/c I could not work with the pain.
I can tell you that Andrew Kolodny has donated 2500.00 to Mary Bono Mack’s committee to push this Petition through. As they say Money talks.

Interesting that Kolodny donates $2500 to Mary Bono Mack’s committee to push the position through. Kolodny has 5 lifetime publications regarding opiate use none of which involve studies on the matter but merely are his opinion. He is a well known politico who has done incredibly well with no objective work. He must be stopped. He only cares to make a name for himself as a leading drug abuse researcher which he assuredly is not

I totally agree with you Hugh, he only wants to make a name for himself.. He doesn’t know shit! He didn’t even know what Arachnoiditis was until all of us wrote to him and told him how we suffer daily and without our meds we would be totally bed bound. There have been studies done on long term use with chronic pain but they are all older ones with the most recent being in 2007. It was funny too that Mary Bono Mack didn’t make it this year in congress..Now who is going to give his money too..lol

(Karma is a Bitch) is not just a saying, in fact the older I get the more I find that it applies to myself and other’s that I have known-both the ones I love and others who I have little empathy. Klonody & Mack and the other unfortunate members of PROP will in one way or another be recipients of the immutable law of cause and effect. A few will be fortunate enough no to suffer much and enjoy a quick death i.e. instant death from accident, dropping dead from heart attack.. the rest will get to experience what we already are. The hell of chronic severe pain, the kind where you don’t sleep more than an hour or two a night. The emotional toll it takes on a relationship when you are unable to “perform” as one use to with a spouse. The finacial impact of wages and jobs lost. The worst is the constant pain somewhat made bearable with opiods, the pain that you keep to yourself. The one you know no one wants to hear about or worse you are hesitent to mention to anyone. The pain that is always their. Yes medication helps. I can walk now, I will never run again. Putting on a happy face when you see the DR. or friend. Who wants to listen to a guy who whines about his pain all the time. Right? I will not bore you with all the details of my life other than to say 4 back surgeries, chronic pain and Methadone 110mg daily.
Call me insensitive, mean, crazy. I don’t care. My hope is that the people involved in this barbaric proposition will one day suffer, suffer greatly from the God of Pain. We live in a world of Karma-my believe. What a great irony to one day see these fools with tears of pain in their cruel eyes.

Damn bro, I hear you 5X5 from a big tall tree!!!! AS we used to say in the war. I know the feeling of the “happy face”. Hell, I have done that with my wife, son, grandbaby, anyone. Friends last OCT. when I happened to get together with them in Texas. I had to have a happy face, hell, I could barely walk. It was a cold night, and I kept the happy face on. I don’t wish bad stuff on anyone, but, I do wish these “cold bastards” would realize that this is so far from being a joke, it’s making us desperate everytime we hear one word from promp. Crap, I’m getting my B/P up, I’m an OLD SOLDIER, and I gotta take it easy, but remember “ZIGMAN”, I’m on your side my friend!!!! I’m on your side, and I got your “6″, (back) 100%,,,,,,,,,,,,,,,,,,,,,doc neeland,,,,,,,,I’m not a doctor, I was a medic.

I am preparing an FDA comment. They have to be submitted before April 8th. There are many doctors, patients and others speaking out. I’ll try to find the link where you submit your comments which can be anonymous. lolololol You can submit a video presentation too and i am working on mine but it has to be 7 minutes or less. Please feel free to contact me if you have anything you want me to say in your or anyone’s behalf. I am sorry these people are doing this because it will in no way address their concerns but will bring so many more suffering. HUGS to all if it didn’t hurt so bad! Thank God they’re virtual!

1- all their recommendations are evidence based on patients without definitive pathology. I.e Low back pain”, fibro, etc,

2- all this would change is drug companies could not advertise outside those guidelines. It would not restrict or change any physician or patient’s ability to use or prescribe on any way. Our most effective chronic pain meds, gabapentin, elavil, etc cannot be advertised by drug companies for chronic pain since they don’t have the indications, but smart docs use them. A huge amount of med use is “off label”.

The Problem is Pain Doc, if PROP gets their way there will be problems, first off if they change the labeling, do you think that Doctor’s will write off label for opioids? Will Insurance companies pay for these medications? I believe that is a worry that all of us with chronic pain have..
Becky